Cited by 719Gastrointestinal motility and disordersPsychosomatic Disorders and Their TreatmentsGastroesophageal reflux and treatments

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Development and Validation of the Rome IV Diagnostic Questionnaire for Adults

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Palsson, Olafur S., Whitehead, William E., van Tilburg, Miranda A.L., Chang, Lin, Chey, William, Crowell, Michael D., Keefer, Laurie, Lembo, Anthony J., Parkman, Henry P., Rao, Satish S.C., Sperber, Ami, Spiegel, Brennan, Tack, Jan, Vanner, Stephen, Walker, Lynn S., Whorwell, Peter, Yang, Yunsheng·2016·Gastroenterology

DOI 10.1053/j.gastro.2016.02.014

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Abstract

The Rome IV Diagnostic Questionnaires were developed to screen for functional gastrointestinal disorders (FGIDs), serve as inclusion criteria in clinical trials, and support epidemiological surveys. Separate questionnaires were developed for adults, children/adolescents, and infants/toddlers. For the adult questionnaire, we first surveyed 1,162 adults without gastrointestinal disorders, and recommended the 90 th percentile symptom frequency as the threshold for defining what is abnormal. Diagnostic questions were formulated and verified with clinical experts using a recursive process. The diagnostic sensitivity of the questionnaire was tested in 843 patients from 9 gastroenterology clinics, with a focus on clinical diagnoses of irritable bowel syndrome (IBS), functional constipation (FC), and functional dyspepsia (FD). Sensitivity was 62.7% for IBS, 54.7% for FD, and 32.2% for FC. Specificity, assessed in a population sample of 5,931 adults, was 97.1% for IBS, 93.3% for FD, and 93.6% for FC. Excess overlap among IBS, FC, and FD was a major contributor to reduced diagnostic sensitivity, and when overlap of IBS with FC was permitted, sensitivity for FC diagnosis increased to 73.2%. All questions were understandable to at least 90% of individuals, and Rome IV diagnoses were reproducible in ¾ of patients after one month. Validation of the pediatric questionnaires is ongoing.

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Method
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Method
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Self-citation
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Self-citation
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Method
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“Rome IV Questionnaire The Rome IV questionnaire is developed to diagnose functional gastrointestinal disorders (FGID) [36].”
Background
Significant Differences in Gut Microbiota Between Irritable Bowel Syndrome with Diarrhea and Healthy Controls in Southwest China
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“According to Rome IV diagnostic criteria, patients with IBS were divided into four types: IBS with diarrhea (IBS-D), IBS with constipation (IBS-C), IBS with constipation/diarrhea (IBS-M), and IBS unclassifiable (IBSU) [2].”
Method
The Prevalence of Irritable Bowel Syndrome and Its Relation to Psychiatric Disorders Among Citizens of Makkah Region, Saudi Arabia
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Self-citation
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Baaleman, D. F., Benítez, C. A. V., Méndez‐Guzmán, L. M., Benninga, M. A., & Saps, M. (2021) · Journal of Neurogastroenterology and Motility · doi:10.5056/jnm20179 · Cited by 14
A comparative study of disorders of gut–brain interaction in Western Europe and Asia based on the Rome foundation global epidemiology study
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Self-citation
Dental evaluation is helpful in the differentiation of functional heartburn and gastroesophageal reflux disease
Helle, K., Árok, A. Z., Ollé, G., Antal, M. Á., & Rosztoczy, A. I. (2023) · World Journal of Gastroenterology · doi:10.3748/wjg.v29.i31.4774 · Cited by 14
Prevalence and factors associated with irritable bowel syndrome among medical students in a Malaysian private university: a cross sectional study
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“Pittsburgh Sleep Quality Index (PSQI) screens for poor sleep quality [12-14].”
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Self-reported IBS and gastrointestinal symptoms in the general population are associated with asthma, drug consumption and a family history of gastrointestinal diseases
Ruderstam, H., & Ohlsson, B. (2022) · Scandinavian Journal of Gastroenterology · doi:10.1080/00365521.2022.2031281 · Cited by 14
A pilot study of visceral fat and its association with adipokines, stool calprotectin and symptoms in patients with diverticulosis
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Postinfection Irritable Bowel Syndrome Following Clostridioides difficile Infection
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Did Age at Surgery Influence Outcome in Patients With Hirschsprung Disease? A Nationwide Cohort Study in the Netherlands
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“They are well-known, validated, and widely used (25,43).”
Background
Causal relationships between psychological disorders and functional gastrointestinal disorders: a bidirectional two-sample Mendelian randomization study
Liu, T., Wang, Z., Kang, X., Wang, X., Ren, G., Lv, Y., Li, J., Liu, Y., Liang, S., Nie, Y., et al. (2024) · European Journal of Gastroenterology & Hepatology · doi:10.1097/meg.0000000000002825 · Cited by 15
Association of Migraine and Irritable Bowel Syndrome in Saudi Arabia: A Nationwide Survey
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Prevalence and associated factors of chronic constipation among Japanese university students
Vu, N. T. H., Quach, D. T., Miyauchi, S., Luu, M. N., Yoshida, M., Nguyen, D. T. N., Yoshino, A., Miyaka, Y., Okamoto, Y., Oka, S., et al. (2024) · Frontiers in Public Health · doi:10.3389/fpubh.2024.1258020 · Cited by 14
A Comprehensive Look at Irritable Bowel Syndrome and its Associated Factors Considering the Rome IV Criteria: A Penalized Smoothly Clipped Absolute Deviation Regression Approach in the Pars Cohort Study
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Association of Peroxiredoxin 1 and brain-derived neurotrophic factor serum levels with depression and anxiety symptoms in patients with irritable bowel syndrome
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Assessing Diagnostic Performance of Modifications to the Rome IV Criteria for Irritable Bowel Syndrome
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Wespi, N., Vavricka, S. R., Brand, S., Aepli, P. R., Burri, E., Misselwitz, B., Seibold, F., Hruz, P. L., Peyrin‐Biroulet, L., Schoepfer, A. M., et al. (2024) · United European Gastroenterology Journal · doi:10.1002/ueg2.12657 · Cited by 12
“19 Prevalence of fecal urgency appears to be particularly high during disease flares, which goes in line with previous findings from Kulyk et al. and Wang et al. showing that presence of urgency is associated with disease activity.”
Superior Mesenteric Artery Syndrome May Be Overlooked in Women with Functional Dyspepsia
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Enhanced electrogastrography: A realistic way to salvage a promise that was never kept?
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Hypnotherapy for irritable bowel syndrome: patient expectations and perceptions
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Self-citation
Twenty-year Outcomes of a Pediatric Chronic Abdominal Pain Cohort: Early Adulthood Health Status and Offspring Physical and Behavioral Health
Stone, A. L., Epstein, I., Bruehl, S. P., Garber, J., Smith, C. A., & Walker, L. S. (2022) · Journal of Pain · doi:10.1016/j.jpain.2022.09.007 · Cited by 15
Self-citation
Dietary Patterns Are Associated With Variations in the Global Prevalence and Severity of Rome IV Irritable Bowel Syndrome
Jaafari, H., Houghton, L. A., West, R. M., Shuweihdi, F., Staudacher, H. M., Nikolova, S., Ford, A. C., Whorwell, P. J., Bangdiwala, S. I., Palsson, O. S., et al. (2025) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2025.06.004 · Cited by 12
Self-citation
Global Prevalence, Characterization, and Impact of Functional Bowel Disorders
Tornkvist, N. T., Palsson, O. S., Hreinsson, J. P., Sperber, A. D., Bangdiwala, S. I., Törnblom, H., & Simrén, M. (2025) · The American Journal of Gastroenterology · doi:10.14309/ajg.0000000000003782 · Cited by 11
Self-citation
Psychosocial quality-of-life correlates in functional gastrointestinal disorders
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The effect of starch- and sucrose-reduced diet accompanied by nutritional and culinary recommendations on the symptoms of irritable bowel syndrome patients with diarrhoea
Gayoso, L., García‐Etxebarria, K., Arzallus, T., Montalvo, I., Lizasoain, J., D’Amato, M., Etxeberría, U., & Bujanda, L. (2023) · Therapeutic Advances in Gastroenterology · doi:10.1177/17562848231156682 · Cited by 12
Association of mental health conditions and functional gastrointestinal disorders among Vietnamese new-entry medical students
Tran, T. T. T., Luu, M. N., Tran, L. L., Nguyen, D., Quach, D. T., & Hiyama, T. (2023) · PLoS ONE · doi:10.1371/journal.pone.0289123 · Cited by 11
Update in diagnosis and management of irritable bowel syndrome
Hung, T.-H., Wang, C.-Y., & Lee, H.-F. (2023) · Tzu-Chi Medical Journal · doi:10.4103/tcmj.tcmj_104_23 · Cited by 15
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Method
Fatigue in Patients with Inflammatory Bowel Disease in Remission One Year After Diagnosis (the IBSEN III Study)
Holten, K. I. A., Bernklev, T., Opheim, R., Olsen, B. C., Detlie, T. E., Strande, V., Ricanek, P., Cetinkaya, R. B., Bengtson, M., Aabrekk, T. B., et al. (2024) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjae170 · Cited by 11
Impact of resistant starch type 3 on fecal microbiota and stool frequency in Thai adults with chronic constipation randomized clinical trial
Luk-in, S., Leepiyasakulchai, C., Saelee, C., Keeratichamroen, A., Srisangwan, N., Ponprachanuvut, P., Chammari, K., Chatsuwan, T., Wannigama, D. L., Shein, A. M. S., et al. (2024) · Scientific Reports · doi:10.1038/s41598-024-79465-1 · Cited by 11
Derivation and validation of a diagnostic test for irritable bowel syndrome using latent class analysis
Sood, R., Gracie, D. J., Gold, M. J., To, N., Pinto-Sánchez, M. I., Berčík, P., Moayyedi, P., Ford, A. C., & Law, G. R. (2017) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.13949 · Cited by 11
Peroxiredoxin 1 as an inflammatory marker in diarrhea‐predominant and postinfectious irritable bowel syndrome
Zhang, Y., Wu, X., Li, S., Jinfeng, W., Han, S., Lin, Z., Ding, S., & Gong, W. (2019) · Neurogastroenterology & Motility · doi:10.1111/nmo.13741 · Cited by 11
Noninvasive bladder testing of adolescent females to assess visceral hypersensitivity
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Self-citation
Association between multiple sleep dimensions and functional bowel disorders among Chinese college freshmen
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Efficacy of whole system ayurveda protocol in irritable bowel syndrome – A Randomized controlled clinical trial
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“The prevalence of all 22 DGBI that can be diagnosed with the Rome IV diagnostic questionnaire, 22 as well as demographic information, somatic symptom severity, quality of life, and healthcare utilization, self-reported diseases, and concern were compared between these age groups.”
BackgroundResultInfluentialSelf-citation
Anhedonia and functional dyspepsia in obese patients: Relationship with binge eating behaviour
Santonicola, A., Gagliardi, M., Asparago, G., Carpinelli, L., Angrisani, L., & Iovino, P. (2020) · World Journal of Gastroenterology · doi:10.3748/wjg.v26.i20.2632 · Cited by 11
Cohort Profile: The Christchurch IBS cOhort to investigate Mechanisms FOr gut Relief and improved Transit (COMFORT)
Heenan, P. E., Creemers, R. H., Sharma, S., Keenan, J. I., Bayer, S. B., Young, W., Cooney, J. M., Armstrong, K., Fraser, K., Skidmore, P. M. L., et al. (2020) · Inflammatory Intestinal Diseases · doi:10.1159/000508160 · Cited by 12
Prevalence and Associated Dietary Factors of Rome IV Functional Gastrointestinal Disorders in Rural Western Honduras
Norwood, D. A., Dominguez, L. B., Paredes, A. A., Montalvan-Sanchez, E. E., Rodriguez-Murillo, A. A., Dougherty, M., Palsson, O. S., Domínguez, R. L., & Morgan, D. R. (2020) · Digestive Diseases and Sciences · doi:10.1007/s10620-020-06639-y · Cited by 13
“, palpable abdominal mass); and history of gastrointestinal cancer, inflammatory bowel disease, gastrointestinal surgery, or significant psychiatric disease [34].”
BackgroundMethodSelf-citation
Epidemiology and Burden of Disorders of Gut-Brain Interaction in Romania: A Subgroup Analysis of the Rome Foundation Global Epidemiology Study
Dumitrascu, D. L., Freud, T., Ismaiel, A., Bangdiwala, S. I., Palsson, O. S., & Sperber, A. D. (2022) · Journal of Gastrointestinal and Liver Diseases · doi:10.15403/jgld-4380 · Cited by 11
Self-citation
The Prevalence and Burden of Avoidant/Restrictive Food Intake Disorder ( ARFID ) Symptoms in the Adult General Population of the UK and USA
Brownlow, G., Flack, R., Murray, H. B., Pálsson, Ó., & Aziz, I. (2025) · International Journal of Eating Disorders · doi:10.1002/eat.24588 · Cited by 10
Prevalence of urinary incontinence and other pelvic floor disorders in women with myotonic dystrophy type 1
Fisette-Paulhus, I., Gagnon, C., & Morin, M. (2022) · Neuromuscular Disorders · doi:10.1016/j.nmd.2022.11.003 · Cited by 10
Investigating the association between the symptoms of women with Fibromyalgia, Digestive function, and markers of the microbiota of the Gastrointestinal Tract (The FIDGIT Study): study protocol
Erdrich, S., Hawrelak, J. A., Myers, S. P., Vuyisich, M., & Harnett, J. (2023) · BMC Musculoskeletal Disorders · doi:10.1186/s12891-023-06259-3 · Cited by 10

Authors: Palsson, O. S., Whitehead, W. E., van Tilburg, M. A. L., Chang, L., Chey, W., Crowell, M. D., Keefer, L., Lembo, A. J., Parkman, H. P., Rao, S. S. C., Sperber, A., Spiegel, B., Tack, J., Vanner, S., Walker, L. S., Whorwell, P., & Yang, Y.
Affiliations: University of North Carolina at Chapel Hill (US)
University of California, Los Angeles (US)
Michigan Medicine (US)
Mayo Clinic in Arizona (US)
Northwestern University (US)
Harvard University (US)
Temple University (US)
Augusta University (US)
KU Leuven (BE)
Kingston General Hospital (CA)
Vanderbilt University Medical Center (US)
Chinese PLA General Hospital (CN)
Corresponding author: Palsson, Olafur S.
ORCID: Palsson, Olafur S.
Whitehead, William E.
Chang, Lin
Chey, William
Crowell, Michael D.
Keefer, Laurie
Lembo, Anthony J.
Parkman, Henry P.
Rao, Satish S.C.
Sperber, Ami
Spiegel, Brennan
Tack, Jan
Vanner, Stephen
Walker, Lynn S.
Whorwell, Peter
Yang, Yunsheng
Venue: Gastroenterology
Publisher: Elsevier BV
Published: 2016-05
Volume: 150
Issue: 6
Pages: 1481-1491
ISSN: 0016-5085 (ISSN-L)
DOI: 10.1053/j.gastro.2016.02.014
OpenAlex: W2344547018
Cited by: 719
References: 19
Citations by year: 2026: 79 · 2025: 99 · 2024: 92 · 2023: 88 · 2022: 70 · 2021: 92 · 2020: 76 · 2019: 41 · 2018: 46 · 2017: 24 · 2016: 10
FWCI: 43.99
Type: journal article
Language: en
Open access: green
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Gastroenterology (publishedVersion)
PubMed (publishedVersion)
Research Explorer (The University of Manchester) (publishedVersion)
Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
UNC Libraries
Topics: Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
Health Sciences › Medicine › Psychiatry and Mental health › Psychosomatic Disorders and Their Treatments
Health Sciences › Medicine › Gastroenterology › Gastroesophageal reflux and treatments
Keywords: Rome IV criteria, functional gastrointestinal disorders, irritable bowel syndrome, functional constipation, functional dyspepsia, sensitivity and specificity, diagnostic overlap, reproducibility, questionnaire validation, adults

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Development and Validation of the Rome IV Diagnostic Questionnaire for Adults

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